Packaging Engineer II- Ave Maria, FL.

1 month ago

Immokalee, United States Arthrex Full time
Requisition ID: 60622 Title: Packaging Engineer II- Ave Maria, FL. Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL.

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing is currently seeking a Packaging Engineer II. The Engineering II will provide packaging engineering support for design engineering projects. Support and assist packaging engineering development goals in support of overall business goals. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Hours - Monday- Friday, 8:00am - 5:00pm

Essential Duties and Responsibilities:

Coordinate Packaging Development activities for new MPI's and product improvement projects. This may include but is not limited to the following:
  • Create and maintain packaging engineering specifications utilizing CAD, 3D modeling software, or other software tools.
  • Create and maintain packaging designs for sterile and non-sterile products.
  • Select appropriate packaging materials based on product and sterilization requirements.
  • Create and maintain Packaging Instruction documents for the final manufacturing packaging assembly of finished devices.
  • Communicate (not execute) packaging process validation activities with manufacturing or designated design team member for Arthrex products.
  • Coordinate and execute packaging design validation activities post packaging process approval.
  • Oversee any required package testing to assure viability of packaging/product construct for sterile and non-sterile barrier protection.
  • Generating protocols, test reports, and engineering adoptions and maintenance of test documentation per approved documentation system per quality standards.
  • Ensure essential packaging development activities are completed prior to packaging design transfer activities.
Coordinate Instrument Case development activities for new MPI's and product improvement projects. This may include but is not limited to the following:
  • Coordinate and Create Instrument Case Layouts with Design Team and Contract Suppliers.
  • Create and maintain Instrument Case Specifications.
  • Oversee Design Verification and Validation activities for Instrument Cases.
  • Lead Instrument Case project when Instrument Case is a standalone MPI.
  • Provide support for packaging engineering related CAPA's.
  • Provide supporting packaging documentation to Regulatory and Quality for 510(k) and ERC submissions and audits.
  • Create Bill of Materials and generate Engineering Change Orders (ECO) in support of new products and various revisions or maintenance.
  • Communicate effectively with Design Team members and Contract Suppliers using project management tools, written, and verbal communication.
  • Support product design changes to develop and improve existing products that affect existing packaging.
  • Oversee any required package testing to assure viability of packaging/product construct and sterile barrier protection. This includes
  • Provide supporting packaging documentation to Regulatory and Quality for 510(k) and ERC submissions and audits.
  • Create Bill of Materials and generate Engineering Change Orders (ECO) in support of new products and various revisions or maintenance.
  • Communicate effectively with Design Teams and Contract Suppliers using project management tools, written, and verbal communication.


Knowledge

Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.

Reasoning Ability

Develops solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.

Discretion/Latitude

Works under general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.

Skills
  • Proficiency in Packaging Design Development requirements as required by quality and regulatory standards.
  • Proficiency in using CAD software for designing, creating, and maintaining sterile and non-sterile packaging components.
  • Proficiency in creating packaging specifications for sterile and non-sterile components.
  • Proficiency in creating packaging components and specifications for sterile and non-sterile packaging components.
  • Proficient at writing and creating Packaging Instructions for non-sterile and sterile packaging assemblies.
  • Proficient at writing protocols, test reports, and adoptions for packaging engineering studies.
  • Basic Knowledge of ISO 11607, ISTA, and ASTM Test standards associated with Medical Device Packaging.
  • Proficient knowledge of packaging validation test standards and equipment.
  • Proficient knowledge of design, manufacturing, and inspection methods and processes.
  • Proficient at developing engineering specifications and drawing conventions that align with Engineering and Quality standards.
Education/ Experience
  • B.S. in Engineering required; preferably in Packaging Engineering
  • Minimum of 2 Yrs. experience in Packaging Design and Development or Manufacturing required
  • Medical device packaging or manufacturing environment experience preferred
Reasoning Ability:

Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the

essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate.

Arthrex 2024 Benefits
  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)


All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

  • Cleaning Tech I- First Shift

    4 weeks ago

    Immokalee, United States Arthrex Full time

    Requisition ID: 60306 Title: Cleaning Tech I- First Shift - Ave Maria, FL. Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL. Arthrex, Inc. is a global medical device company and a leader in new product development and medical educationArthrex Manufacturing is actively searching for a Cleaning Tech I on First Shift. The successful...

  • Senior Engineer

    3 weeks ago

    Immokalee, United States Arthrex Full time

    Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and...

  • Clean Room Assembler

    41 minutes ago

    Immokalee, United States Arthrex Full time

    Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and...

  • Retail Sales Associate

    3 months ago

    Immokalee, United States Goodwill Industries of Southwest Florida Full time

    Job DescriptionJob DescriptionGoodwill INDUSTRIES OF Southwest Florida, INC.Retail Sales AssociateFull time Location: Ave Maria - Store #159Based in Fort Myers, Florida, Goodwill of Southwest Florida is committed to serving people with disabilities and disadvantages by offering life-changing opportunities to achieve independence., Goodwill Industries of...

  • Senior Business Analyst

    2 weeks ago

    Immokalee, United States Arthrex Full time

    Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and...

  • Machinist I

    2 weeks ago

    Immokalee, United States Arthrex Full time

    Requisition ID: 60396 Title: Machinist I - Swiss - 2nd Shift Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing is looking to hire a Swiss Machinist I at our Ave Maria, FL location. Five years or...

  • Molding Operator

    2 weeks ago

    Immokalee, United States Arthrex Full time

    Requisition ID: 60587 Title: Molding Operator - Injection Molding I - 1st Shift Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria. FL Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. This position is to produce superior products following Arthrex Manufacturing Inc....

  • Molding Operator

    2 weeks ago

    Immokalee, United States Arthrex Full time

    Requisition ID: 60588 Title: Molding Operator - Injection Molding I - 2nd Shift Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria. FL Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. This position is to produce superior products following Arthrex Manufacturing Inc....

  • Cleaning Tech I- First Shift

    3 months ago

    Immokalee, United States Arthrex Full time

    Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and...

  • Machinist I

    2 weeks ago

    Immokalee, United States Arthrex Full time

    Requisition ID: 60396 Title: Machinist I - Swiss - 2nd Shift Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing is looking to hire a Swiss Machinist I at our Ave Maria, FL location. Five years...

  • Cleaning Tech I, 2nd Shift

    1 month ago

    Immokalee, United States Arthrex Full time

    Performs In-Process & Final Cleaning and Passivation of products and components in accordance with work instructions. Performs terminal cleaning and daily housekeeping utilizing various cleaning and disinfecting agents. Performs manual device assembl Cleaning, 2nd Shift, Tech, Shift, Healthcare, Instruction, Skills

  • Cleaning Tech I, 2nd Shift

    2 months ago

    Immokalee, United States Arthrex Full time

    Performs In-Process & Final Cleaning and Passivation of products and components in accordance with work instructions. Performs terminal cleaning and daily housekeeping utilizing various cleaning and disinfecting agents. Performs manual device assembl Cleaning, 2nd Shift, Tech, Shift, Healthcare, Instruction, Skills

  • Cleaning Tech I- First Shift

    4 months ago

    Immokalee, United States Arthrex Full time

    Performs In-Process & Final Cleaning and Passivation of products and components in accordance with work instructions. Performs terminal cleaning and daily housekeeping utilizing various cleaning and disinfecting agents. Performs manual device assembl Cleaning, Tech, Shift, Healthcare, Instruction, Skills

  • Barista

    2 weeks ago

    Immokalee, United States Aladdin Campus Dining Full time

    Barista Job Reference Number: 23247 Employment Type: Part-Time, Onsite Segment: Education Brand: Aladdin-Campus-Dining State: Florida (US-FL) The Role at a glance: We are looking to add an energetic, motivated barista to our Higher Education team in Immokalee, FL. As a barista, you will have the opportunity to serve a diverse clientele daily, providing...

  • Cashier

    1 month ago

    Immokalee, United States Aladdin Campus Dining Full time

    Cashier Job Reference Number: 22186 Employment Type: Part-Time, Onsite Segment: Education Brand: Aladdin-Campus-Dining State: Florida (US-FL) The Role at a glance: We are looking to add a friendly, enthusiastic cashier to our education team in Immokalee, FL. As a cashier with Aladdin Campus Dining, you will have the opportunity to interact with a plethora...

  • Textile Engineer Technician I-Weekend

    3 weeks ago

    Immokalee, United States Arthrex Full time

    Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and...

  • Textile Engineer Technician I- 2nd Shift

    3 weeks ago

    Immokalee, United States Arthrex Full time

    Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and...

  • Textile Engineer Technician I-Weekend

    3 weeks ago

    Immokalee, United States Arthrex Full time

    Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and...

  • Practice Manager

    1 month ago

    Immokalee, United States Integrative Emergency Services Full time

    Job DescriptionJob DescriptionPOSITION SUMMARYIntegrative Health is a network of independent physician-owned practices. We are committed to providing an alternative to the traditional private equity healthcare models by empowering independent practices with stability, support, and growth opportunities. We unite independent practice sites across Florida,...

  • Suture Assembly Operator

    3 weeks ago

    Immokalee, United States Arthrex Full time

    Requisition ID: 60463 Title: Suture Assembly Operator - 2nd Shift Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. Arthrex Manufacturing is actively searching for Suture Assembly Operators to produce quality medical instruments...